Lawyers spar as Plavix patent trial begins
By Martha Graybow
NEW YORK, Jan 22 (Reuters) - A lawyer for Sanofi-Aventis (SASY.PA) and Bristol-Myers Squibb Co. (BMY.N) urged a U.S. judge to uphold the patent on blockbuster anti-clotting medication Plavix on Monday, as a high-stakes trial over the drug's future got under way.
Sanofi and Bristol-Myers are trying to protect Plavix from competition with a cheaper version made by generic drug maker Apotex Inc., a privately held Canadian company that sold its copycat drug in the United States briefly last year before the U.S. court stopped the shipments.
In opening arguments in U.S. District Court in Manhattan, Evan Chesler, a lawyer for Sanofi and Bristol-Myers, said Apotex had no legal basis for its argument that the drug's patent should be invalidated.
"They have basically rewritten history," he said, arguing before District Judge Sidney Stein, who is hearing the case without a jury.
But Apotex lawyer Robert Breisblatt said the patent should not be allowed to stand, in part because the formula for the drug would have been "obvious" to another scientist in the field.
"It is invalid because it is obvious," he said in his opening statement.
Apotex has been challenging the patent since 2002, arguing it is not truly innovative but is based on the patent for a molecule which expired in 2003 and which provided information on how to make clopidogrel bisulfate, Plavix's chemical name.
New York-based Bristol-Myers sells Plavix in the United States for Sanofi, which is based in Paris.
Plavix had annual sales of $6 billion before the Apotex copy hit the U.S. market. The drug is Bristol-Myers' biggest-selling medicine. Sales of the generic have posed a serious threat to Bristol-Myers' earnings.
Many pharmaceutical analysts have predicted Sanofi and Bristol will prevail in the patent infringement trial, in large part because Judge Stein previously granted a preliminary injunction in their favor.
In that ruling, issued in August and later upheld by an appeals court, Stein concluded that Apotex had failed to raise substantial questions about the patent.
The trial is expected to last about four weeks, with a decision by the judge likely to come several months after that.
((Reporting by Martha Graybow, editing by Gerald E. McCormick; Reuters Messaging: martha.graybow.reuters.com@reuters.net; +1-646-223-6133)) Keywords: PLAVIX/TRIAL
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